格隆汇11月24日丨君实生物(688180.SH)公布，近日，公司产品特瑞普利单抗注射液（皮下注射）对比 特瑞普利单抗注射液（商品名：拓益®，产品代号：JS001）联合化疗一线治疗复发或转移性非鳞状非 小细胞肺癌的多中心、开放、随机对照 III 期临床研究（JS001sc-002-III-NSCLC研究，NCT06505837） 达到主要研究终点。公司计划将于近期向监管部门递交该产品的上市许可申请。 以抗PD-1单抗为代表的肿瘤免疫治疗（I-O）已成为包括肺癌、乳腺癌、肝癌、食管癌、鼻咽癌等多种 恶性肿瘤治疗的基石类疗法，并基本覆盖了肿瘤患者的全程治疗，包括早期肿瘤的辅助/新辅助治疗、 局部晚期肿瘤根治性放化疗后的巩固治疗以及晚期肿瘤的一线到末线治疗。目前国内免疫治疗药物以静 脉输注制剂为主，不仅输注耗时较长，也给患者治疗带来诸多不便，临床对提升免疫治疗的便捷性有迫 切需求。 JS001sc-002-III-NSCLC 研究是一项多中心、开放、随机对照的III 期临床研究，为国产 PD-1 药物皮下 制剂的首个 III 期临床研究，由湖南省肿瘤医院邬麟教授担任主要研究者。该研究旨在比较 JS001sc 和 特 ...

Core Viewpoint - Cancer immunotherapy is emerging as a key treatment method for cancer, following surgery, radiotherapy, and chemotherapy, and is expected to see significant market growth in the coming years [1][6][7]. Group 1: Industry Definition and Classification - Cancer immunotherapy aims to activate or enhance the immune system to target tumor cells, utilizing methods such as cytokine therapy, cancer vaccines, T-cell therapy, and immune checkpoint inhibitors [2][4]. Group 2: Current Development Status - Cancer remains a leading health threat, with over 10 million deaths annually. The global anti-cancer drug market is projected to grow from $150.3 billion in 2020 to $253.3 billion in 2024, with cancer immunotherapy expected to reach $69.91 billion, accounting for 27.60% of the market [4][6][7]. Group 3: Industry Chain - The cancer immunotherapy industry chain includes upstream activities such as basic research and drug design, midstream development and production, and downstream medical institutions and testing agencies [8]. Group 4: Development Environment and Policies - Cancer is the leading cause of death globally, with a low early diagnosis rate in China. The government has implemented policies to enhance cancer prevention and treatment, such as the "Healthy China Action - Cancer Prevention and Control Action Implementation Plan (2023-2030)" [9]. Group 5: Competitive Landscape - The cancer immunotherapy market is characterized by concentrated leadership and technological differentiation, with key players including Legend Biotech, Akeso, I-Mab, Junshi Biosciences, and others. Notable advancements have been made in CAR-T, bispecific antibodies, and NK therapies [10][11]. Group 6: Future Development Directions - While cancer immunotherapy has transitioned from laboratory concepts to clinical practice, challenges such as resistance, toxicity, and accessibility remain. Future advancements may lead to a shift from "prolonging survival" to "functional cure" through interdisciplinary innovation and policy support [12][13].

Core Viewpoint - Junshi Biosciences has raised approximately HKD 1.026 billion through a discounted placement of H-shares, reflecting significant cash flow pressures and concerns regarding the sustainability of its financing and R&D model [2][4]. Financing and Capital Structure - The recent placement at HKD 25.35 per share represents an 11.52% discount, marking the largest discount financing in the Hong Kong biopharmaceutical sector this year [2]. - This is the third large-scale financing for Junshi Biosciences in four years, with total fundraising since 2021 reaching approximately RMB 7 billion [3]. - The company has accumulated losses exceeding RMB 10.9 billion since its establishment in 2012, with R&D expenditures totaling RMB 11.419 billion, indicating a heavy reliance on external capital [4]. Financial Performance and Ratios - Junshi's asset-liability ratio increased from 24.64% in 2021 to 47.98% in Q1 2025, indicating rising financial pressure [5][6]. - The company's liquidity ratios have declined significantly, with the current ratio dropping to 1.40 and the quick ratio to 1.20 in Q1 2025, both below industry averages [6][8]. - Cash reserves have decreased from a peak of RMB 6.031 billion at the end of 2022 to RMB 2.522 billion by Q1 2025, a reduction of over 58% [5]. Revenue and Product Dependency - Junshi's revenue heavily relies on its core product, Toripalimab (Tuoyi®), which accounted for over 88% of total revenue in Q1 2025, despite the company still facing losses [9][10]. - The company reported a total revenue of RMB 1.948 billion in 2024, with a net loss of RMB 1.281 billion, although the loss narrowed by 43.90% year-on-year [9]. - International revenue has fluctuated dramatically, dropping from RMB 3.341 billion in 2021 to RMB 0.093 billion in 2024, highlighting instability in the company's revenue structure [10].

Core Viewpoint - The company is preparing for the 2024 Annual General Meeting (AGM) to ensure the rights of shareholders and maintain order and efficiency during the meeting [1][2][3] Group 1: Meeting Procedures - Only eligible shareholders, directors, supervisors, senior management, and other attendees can participate in the AGM, and the company reserves the right to refuse entry to those who do not meet the criteria [2] - The meeting will follow the agenda as notified, and no agenda items can be postponed or omitted from voting [2] - Attendees must maintain order and respect the rights of other shareholders during the meeting, with the company authorized to take measures against disruptions [2][3] Group 2: Shareholder Rights - Shareholders have the right to speak, inquire, and vote during the AGM, with a maximum speaking time of five minutes per shareholder [3] - The meeting will be witnessed by a lawyer from a law firm to provide legal opinions on the proceedings [3] Group 3: Financial Performance - The company reported a significant increase in sales revenue, with a 29.7% rise to 194,832 million yuan compared to 150,255 million yuan in the previous year [28][32] - The company managed to reduce its operating loss significantly, with a decrease in net loss attributed to improved sales efficiency and cost control measures [34] - The total assets of the company at the end of 2024 were 1,078,196 million yuan, a decrease from 1,134,287 million yuan in 2023 [28][30] Group 4: Governance and Board Activities - The company completed the election of the fourth board of directors on June 21, 2024, with 14 members, including 5 independent non-executive directors [9][11] - The board held 13 meetings during the reporting period, approving all agenda items without any rejections [10] - The board established four specialized committees to enhance governance efficiency and decision-making [10][12] Group 5: Future Plans - The company plans to apply for financing and credit limits totaling up to 8 billion yuan to support its operational and project development needs [39] - The board aims to strengthen its governance structure and enhance compliance management in 2025 [13]